Senior Consultant - Digital Validation & IT Compliance

Overview

Senior Consultant for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities within Tech@Lilly's Validation Center of Excellence, ensuring compliance, quality and efficiency across Lilly computer systems and driving the use of AI, digital tools and automation in validation.

What you'll do

• Drive innovation in validation by exploring and leveraging AI, digital tools and automation technologies to streamline validation documentation, authoring and review processes.
• Identify opportunities to simplify CSV/CSA activities through risk-based approaches, automation frameworks and smart documentation solutions, reducing effort while maintaining compliance.
• Continuously evaluate emerging technologies (e.g., AI-assisted authoring, digital validation platforms) and recommend practical use cases for efficiency and quality improvement.
• Identify and drive continuous improvement, automation and simplification opportunities in validation processes using digital tools or AI-enabled solutions.
• Lead and coordinate IT system validation by managing the computer system lifecycle from validation/test planning to reporting, ensuring compliance with regulatory requirements, Lilly processes and validation standards.
• Apply the appropriate right-sizing method/approach and determine the nature and content of deliverables in scope.
• Oversee AI/auto-generated validation documents by reviewing and updating content to ensure accuracy, compliance and alignment with Lilly's quality management system.
• Review all project validation deliverables authored by the project team (developers, SMEs etc.).
• Escalate and communicate operational issues, critical compliance findings and risks to the Information System Quality (ISQ) organization and other key stakeholders of the system.
• Educate project team members on Lilly IT processes and methodologies.
• Collaborate with cross-functional teams to identify and mitigate compliance risks, providing guidance and training on best practices and regulatory requirements.
• Advise the project team on implementation of compliance and security control requirements at the appropriate stages of system development.
• Contribute to internal and external audits, assessments or inspections.
• Ensure IT system change requests (CR) are executed in compliance with local/global change control procedures; review CRs for accuracy and completeness and review the impacted validation deliverables.
• Facilitate and support the system custodian/owner and area management to execute access roster and periodic reviews, followed by respective Corrective and Preventive Action (CAPA) closure.
• Achieve measurable improvements in validation efficiency (e.g., reduced cycle time, higher CSA adoption, increased compliance).
• Contribute to continuous improvement of documentation and validation processes for functional areas.
• Promote simplification and harmonization across systems and geographies.
• Mentor and coach junior validation staff and foster a quality culture across teams.
• Drive CSA adoption to simplify and modernize CSV, focusing on risk-based assurance rather than excessive documentation.

What you'll need

• Bachelor's degree in computer science, Information Technology or a related field.
• Overall 8-10+ years of experience in CSV in the pharmaceutical or life sciences industry.
• Extensive knowledge of GxP, regulatory requirements and IT system validation processes.
• In-depth knowledge of regulations, guidelines and industry standards related to CSV, data integrity and computerized systems, such as GxP, GAMP 5, FDA 21 CFR Part 820, 21 CFR 210, 21 CFR 211, 21 CFR Part 11, EU Annex 11 and ALCOA++ principles.
• Experience leading CSV activities across the full system lifecycle (implementation, upgrades, retirement).
• Expertise in creating documents including, but not limited to, validation plan, system configuration, system overview, security plan and validation report.
• Hands-on expertise in preparing, reviewing and approving validation deliverables.
• Strong knowledge of IT system operational compliance processes, including periodic reviews and access roster reviews.
• Proven ability to apply risk-based validation approaches in alignment with CSA principles to balance compliance with efficiency.
• Hands-on experience with commonly used industry tools (e.g., Jira, ServiceNow, Veeva).
• Demonstrated expertise in leading compliance initiatives and fostering cross-functional collaboration.
• Strong experience in regulatory compliance, validation processes, risk assessment, IT systems change management, stakeholder collaboration, continuous improvement, project management and analytical problem-solving.
• Ability to collaborate with technical and non-technical team members.

Nice to have

• Excellent interpersonal, analytical, problem-solving and investigative skills.
• Strong communication and collaboration skills.
• Knowledge of Agile principles and frameworks (e.g., Scrum, SAFe), including related tools such as Jira.
• Demonstrated leadership skills in influence, team leadership, articulating and taking a position, negotiation and conflict resolution.

Details

• Location: Hyderabad, India.
• Availability for flexible work hours is/may be required.
• The team supports continuous operations across two shifts, so the role requires non-standard work hours and some work on weekends and holidays.
• Appropriate adjustments in benefits will be provided for employees working non-standard hours where applicable.